Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167544
Status:
COMPLETED
Last Update Posted:
2013-08-30
First Post:
2005-09-09
Brief Title:
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes
Detailed Description:
Hypothesis Among extremely low birth weight infants ELBW BW 1000 g at high risk for bronchopulmonary dysplasia BPD and neurologic impairments those infants randomized to seven days of hydrocortisone will demonstrate increased total cerebral tissue volumes as compared to infants randomized to placebo
Specific Aims 1 To perform a pilot blinded randomized controlled trial of a 7-day regimen of low dose hydrocortisone in ELBW infants at high risk for BPD and neurosensory impairments and assess its effect on cerebral tissue volumes 2 Evaluate and report 2 year neurodevelopmental outcomes
Background and Significance Bronchopulmonary dysplasia is a disease of arrested lung development and lung inflammation It is primarily seen in ELBW infants Neurological delay including cerebral palsy and mental retardation affect up to 40-50 of surviving ELBW infants BPD is an important risk factor for such neurological delay Postnatal administration of corticosteroids to ventilated preterm neonates results in a reduced risk of developing BPD Postnatal corticosteroids however have shown harmful effects on the brain and can lead to increased rates of cerebral palsy and learning problems This effect has primarily been seen with dexamethasone when high doses were given in the first week of life Beyond the first week of life there is insufficient information on the effects of steroids on the brain Steroids other than dexamethasone in much lower doses have been shown to improve short term lung function with minimal short-term side effects A review study of all steroid trials for BPD shows that when given to a high risk group of infants 50 risk of BPD steroids protect the brain and reduce rates of cerebral palsy The American and Canadian Pediatric societies and respected researchers have commented on the urgent need for more trials of other corticosteroids at lower doses started after the first week of life to evaluate their short and long-term pulmonary and neurological benefits and risks
Research Design and Methods
1 Inclusion Exclusion Criteria See below
2 Procedures Consented eligible patients will be randomly assigned to receive hydrocortisone in a tapering schedule over 7 days or placebo comparison group Study drug will be given every 12 hours IV with only study pharmacist aware of assignment The patients anatomic brain MRI routinely done on all ELBW infants at 38 weeks post-menstrual age will be further processed by the masked study investigators to derive total and regional brain volumes Administration of indomethacin or dexamethasone to enrolled infants will be closely monitored and regulated throughout the trial period Indomethacin use during study period is contraindicated Dexamethasone or other steroid use will be restricted to ELBW infants on high ventilator settings RIS 10 after 28 days of life All other procedures will be per routine care Blinded developmental follow-up at two years already currently performed for all ELBW infants at MHCH will be analyzed and reported for all study infants
Specific Aims 1 To perform a pilot blinded randomized controlled trial of a 7-day regimen of low dose hydrocortisone in ELBW infants at high risk for BPD and neurosensory impairments and assess its effect on cerebral tissue volumes 2 Evaluate and report 2 year neurodevelopmental outcomes
Background and Significance Bronchopulmonary dysplasia is a disease of arrested lung development and lung inflammation It is primarily seen in ELBW infants Neurological delay including cerebral palsy and mental retardation affect up to 40-50 of surviving ELBW infants BPD is an important risk factor for such neurological delay Postnatal administration of corticosteroids to ventilated preterm neonates results in a reduced risk of developing BPD Postnatal corticosteroids however have shown harmful effects on the brain and can lead to increased rates of cerebral palsy and learning problems This effect has primarily been seen with dexamethasone when high doses were given in the first week of life Beyond the first week of life there is insufficient information on the effects of steroids on the brain Steroids other than dexamethasone in much lower doses have been shown to improve short term lung function with minimal short-term side effects A review study of all steroid trials for BPD shows that when given to a high risk group of infants 50 risk of BPD steroids protect the brain and reduce rates of cerebral palsy The American and Canadian Pediatric societies and respected researchers have commented on the urgent need for more trials of other corticosteroids at lower doses started after the first week of life to evaluate their short and long-term pulmonary and neurological benefits and risks
Research Design and Methods
1 Inclusion Exclusion Criteria See below
2 Procedures Consented eligible patients will be randomly assigned to receive hydrocortisone in a tapering schedule over 7 days or placebo comparison group Study drug will be given every 12 hours IV with only study pharmacist aware of assignment The patients anatomic brain MRI routinely done on all ELBW infants at 38 weeks post-menstrual age will be further processed by the masked study investigators to derive total and regional brain volumes Administration of indomethacin or dexamethasone to enrolled infants will be closely monitored and regulated throughout the trial period Indomethacin use during study period is contraindicated Dexamethasone or other steroid use will be restricted to ELBW infants on high ventilator settings RIS 10 after 28 days of life All other procedures will be per routine care Blinded developmental follow-up at two years already currently performed for all ELBW infants at MHCH will be analyzed and reported for all study infants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSC-MS-05-0218 | US NIH GrantContract | None | httpsreporternihgovquickSearchK23NS048152 |
| K23NS048152 | NIH | None | None |